Track and Trace systems for tracking and tracing of manufactured items is well known in the industry. Counterfeiting affects both the manufacturer and the public. E.g. in the field of pharmaceuticals, fake medicines may have no effect, or they can have dangerous side effects.
The systems used for preventing counterfeiting are implemented in a number of different ways.
One group of technology in the field is concerned with how to mark items and how to read back the information from the items to avoid copying of products. To avoid copying, the items can be marked with invisible markers, encrypted codes, RFID tags etc. It should be difficult for a counterfeiter to discover and decipher the information marked on the item, since this would enable the counterfeiter to copy the items and the marking in a way that would lead a consumer to believe they buy the original product.
Another group of technology is more concerned with how to follow, or trace an item from the manufacture to the end customer. By controlling the supply chain, and especially what happens to the items when being received and shipped in the distribution points, the possibility of successful counterfeiting or other fraudulent activities is reduced. This is commonly referred to as secure track and trace.
A secure track and trace system is surveying and managing all goods having been marked and registered with a unique identifier, and at the same time controlling all parties allowed to handle the products, all the way from the manufacture to the end consumer.
Track and trace systems according to background art works in the way that product items and associated transportation units are marked with a unique identifier. This identifier is then utilized to continuously authenticate the product in the supply chain. If the authentication process has a positive outcome, i.e. the product and code has been determined to be genuine, additional information related to the product and the present stage of the supply chain may be recorded and stored for later retrieval and analysis. The pivotal information that is recorded during the addition of a new tracking record is the identity of the product or transportation unit, the location and the time and also information about the operator. If available, the devices and method by which the product was authenticated, as well as other circumstantial and pertinent information may also be recorded in the tracking record.
This series of tracking records recorded by the track and trace system will result in a complete history of the handling of the product in the supply chain, that might be presented and audited at any time for security or other purposes.
The two groups of technologies described above are often combined to ensure maximum control of the supply chain and the end users confidence in the purchased goods.
European patent publication EP2104067A1 describes a method and apparatus for identifying, authenticating, tracking and tracing manufactured items in containers, where each container is suitable for containing one or more units.
US patent application 2011/0154046A1 describes a method and apparatus for storage of data for a batch of manufactured items. Each item is marked with a unique identifier from a set of unique identifiers within a pre-defined range. The number of unique identifiers is larger than the number of manufactured items, and some of the unique identifiers within the range will not be used. The unused identifiers are identified.
US patent application 2012/0130868A1 discloses a system and a method for tracking and tracing items comprising generating a group of unique codes, wherein each code is a unique encrypted reference, transferring the unique codes to an item marking location and marking the items. An item can be tracked by transferring the code marked on the item to the track and trace system where it is decrypted, and based on the unique code, creating a tracking record in a unique storage location, where the unique reference refers to the unique storage location. A tree structure resembling the packaging hierarchy is disclosed, where the nodes in the tree are referenced by the unique code.
Very seldom a product is sent directly from the factory to the end customer. As an example the smallest sellable item may be a first package of medicine comprising 20 capsules. 10 first packages are stored in a second package, 50 second packages are stored in a third package and 100 third packages are transported on the same pallet from the factory. Then, to continue the example, the pallet is transported to the first distribution point. Here 30 of the third packages on the pallet are loaded onto a new pallet together with other packages. In the next distribution point one of the third packages are unpacked and the 50 second packages inside are put in different new boxes with other goods having the same destination. This re-packaging may go on until the products reach their final destination.
According to the standardization organisation GS1, a traceable item is a physical object where there may be a need to retrieve information about its history, application, or location. The level at which the traceable item is defined within a product packaging or logistical hierarchy is dependent on the industry and degree of control required. A traceable item may be related to another traceable item.
According to the principles of secure track and trace, the location of each packaged item should be traceable at any time. However, usually only the visible items, i.e. the outer packages, and not the inner, are tracked and traced in the distribution points, since it would be impractical to open all packages in every location just to see what they contain. Further, this natural temporarily concealment of the inner items is a security benefit in itself since their unique codes are protected from being known by parties with malicious intents. Various procedures and spot checks can utilize this concealment for security purposes. It is therefore important to know the packaging relationships of an item, e.g. the identity of the third package in the example above comprising the specific traced second package. The specific third package will in this case be the parent. Likewise, if the third package was traced, the identity of all the second packages it contains should be available. The second packages are child items of the third package. In essence the packaging structure that relates all items with all the other items, makes it possible when knowing a given item and its code, to implicitly manage and trace other items and codes based on that said code, without the need to read or otherwise record those codes as such.
Most track and trace systems use tracking records in a database to store information about the items in the supply chain as described above. However, one of the problems with databases is that for very large numbers of items the performance needed to provide an acceptable level of system response time has found to be too unpredictable as well as inadequate, since an index for the large amounts of data has to be managed. For the handling of large-amounts of re-packaged items, this problem increases.
The background art does therefore not disclose how to handle significant volumes of packaging structures and re-packaging of items in the track and trace system during their progress and advance in the supply chain in an effective way.